Kornimate/medical-research-clean huggingface dataset:
desensitization of nociceptive afferents by application of topical capsaicin, trans-cinnamaldehyde and l-menthol

Conditions: Pain; Pruritus; Neuropathic Pain; Dermatology/Skin - Other

Summary: the purpose of this study is to investigate the potential desensitising effects of repeated applications of capsaicin, trans-cinnamaldehyde and l-menthol on thermal, mechanical and chemical sensory stimulations.

capsaicin, the compound responsible for the pungency of chili peppers, can induce desensitization to nociceptive (1) and pruriceptive (2) stimuli when topically applied. the purpose of this study is to determine whether repeated topical applications of trans-cinnamaldehyde and l-menthol result in decreased responses to various nociceptive and non-nociceptive thermal and mechanical stimuli and to compare potential alterations with those caused by repeated topical application of capsaicin. furthermore, this study investigates the temporal profile of said alterations. capsaicin 8% patches, trans-cinnamaldehyde 10%, l-menthol 40% and inert vehicle patches will each be applied to 4 4x4 cm predefined areas on the skin of the volar forearms for 1 hour 4 times on 4 consecutive days. before each application and the day after the last application, cold detection threshold (cdt), warmth detection threshold (wdt), cold pain threshold (cpt) and heat pain threshold (hpt) will be assessed using a medoc pathway (medoc, israel) equipped with a 3x3 cm contact thermode. on the last day, mechanical detection threshold (mdt) is assessed using a series of von frey filaments and mechanical pain threshold (mpt) and mechanical pain sensitivity (mps) is assessed using a series of standardized pinprick stimulators (aalborg university). furthermore, full-field laser perfusion imaging (flpi) will be used to assess the degree of neurogenic inflammation in each predefined area before and after each substance application and at the last session. 1. f. henrich et al. 2015 "capsaicin-sensitive c- and a-fibre nociceptors control long-term potentiation-like pain amplification in humans" 2. h.h. andersen et al. 2017 "antipruritic effect of pretreatment with 8% topical capsaicin on histamine- and cowhage-evoked itch in healthy volunteers - a randomized placebo-blinded proof-of-concept trial"

Eligibility criteria:
inclusion criteria: * healthy * speaks and understands english or danish * 18-60 years exclusion criteria: * pregnancy or lactation * drug addiction * previous or current dermatological, neurological, musculoskeletal or mental illnesses * lack of ability to cooperate * current use of medications that may affect the trial
a study to assess the usability of the embrace seizure detection watch in children and young adults with dravet syndrome

Conditions: Dravet Syndrome

Summary: this is an exploratory sub-study to zx008-1503 \[nct02823145\]. subjects will be fitted with an embrace seizure detection watch and seizures detected by the watch will be compared to those entered into an electronic seizure diary.

this sub study will include up to 20 participants who meet the entry criteria for the main study zx008-1503 and who are willing to wear the embrace watch and use the embrace alert app for 12 consecutive weeks. those invited to participate will undergo all procedures included in the main study during their participation in this sub-study,

Eligibility criteria:
inclusion criteria: * meeting all of the main study zx008-1503 \[nct02823145\] inclusion criteria * subject is willing to wear the embrace watch on the wrist (alternatively ankle, if needed for younger children). subjects are asked to wear the watch for as many hours of the day as possible and for the entire night, if possible, for the duration of the sub-study. * subject's parent/caregiver is willing to use the alert app. * subject/subject's caregiver is willing to ensure that the embrace watch remains within close proximity of the paired ipod touch running the empatica alert app. exclusion criteria: * subject has a known hypersensitivity to any of the embrace device materials. * subject has a clinically significant condition, or has had clinically relevant symptoms or a clinically significant illness in the 4 weeks prior to visit 1, other than epilepsy, that would negatively impact study participation, collection of study data, or pose a risk to the subject.

Keywords: seizure tonic clonic epilepsy myoclonic encephalopathy
photodynamic therapy for cutibacterium acnes (c. acnes) decolonization of the shoulder dermis

Conditions: C. Acnes; Phototherapy; Postoperative Infection; Arthroscopic Rotator Cuff Repair; Shoulder Surgery

Summary: this is a prospective, randomized controlled trial to evaluation the ability of 5-aminolevulinic acid hcl topical solution photodynamic therapy to decrease the colonization of cutibacterium acnes (c. acnes- a bacteria commonly found in the dermis of the skin surrounding the shoulder) in order to decrease postoperative joint infections. -aminolevulinic acid (ala) is a naturally occurring metabolite in the synthesis of pathway of cellular heme production. adding ala to bacteria encourages porphyrin production which serve as the immediate precursors to heme production. when these porphyrins are illuminated with blue light at an emission peak of 407-420nm, these metabolites become exothermic and cause internal destruction of the bacterial cells. this therapy does not cause any damage to the mammalian cells, which makes pdt safe for human skin treatment.


Eligibility criteria:
inclusion criteria: * all male patients (\>18) undergoing shoulder arthroscopy) exclusion criteria: * female patients * patients with active acnes * patients who have taken antibiotics within a month of their surgery * subjects with psoriatic/eczematous lesions on the shoulder girdle * patients on anticoagulant therapy * patients who have a known allergy to any of the agents used in the study protocol
rc48-adc combined with s-1 for first-line treatment of advanced gastroesophageal adenocarcinoma with moderate expression of her2

Conditions: Advanced Gastroesophageal Adenocarcinoma

Summary: this study was a single-arm, open, multi-center phase ib/ii clinical trial to observe and evaluate the efficacy and safety of rc48-adc plus s-1 in first-line treatment of advanced gastroesophageal adenocarcinoma with moderate expression of her2.


Eligibility criteria:
inclusion criteria: * at the same time, patients voluntarily participated in the study and signed informed consent; * either male or female, aged 18 or older; * patients diagnosed by pathological or cytological diagnosis of gastric cancer (gc), gastroesophageal junction carcinoma (gej) or esophageal adenocarcinoma had evidence of local advanced lesions or metastases that could not be surgically resected, and were mostly adenocarcinoma confirmed by histological examination; * no previous systemic therapy; or had received neoadjuvant/adjuvant chemotherapy but experienced disease progression or recurrence 6 months after the end of treatment; * her2 ihc 2+ and fish-; * ecog scores 0-1; * estimated survival ≥3 months; * women of reproductive age had to undergo a pregnancy test (serum or urine) which was negative within 7 days of enrollment, and volunteer to use an appropriate method of contraception during the observation period and for 12 weeks after the last study drug was given. for men, surgical sterilization or consent to use appropriate methods of contraception during the observation period and for 12 weeks after the last administration of the study drug; * patients who comply are expected to be able to follow up on therapeutic outcomes and adverse reactions as required by the regimen. exclusion criteria: * five years before first use of the study drug has been diagnosed as other malignant tumor, the effective treatment of basal cell carcinoma, squamous cell carcinoma of the skin and/or the effective removal of cervical cancer in situ and/or except breast cancer; * known hypersensitivity to rc48-adc; * hbv dna\>500 iu/ ml (or 2000 copies /ml), hcv rna\>103 copies /ml, hbsag+ and anti-hcv antibody positive; * history of hiv infection; * history of receiving any anti-cancer drug/biologic treatment within 4 weeks prior to trial treatment; * assessed by the investigator to be unable or unwilling to comply with the requirements of the protocol.
the effect of febuxostat on coronary plaque volume in patients with chronic stable angina and hyperuricemia

Conditions: Coronary Artery Disease

Summary: the purpose of this study is to investigate the effects of febuxostat on coronary plaque volume in patients with chronic stable angina and hyperuricemia.

patients with stable angina and hyperuricemia who undergo percutaneous coronary intervention (pci) with intravascular ultrasound (ivus) are enrolled. participants will be randomly assigned to one of the two treatment groups. febuxostat group and a lifestyle modification group. at 8-12 months, routine follow up angiography and ivus interrogation as well as endothelial function and several bio markers will be assessed.

Eligibility criteria:
inclusion criteria: 1. patients 20 years of age or older at enrollment who are able to visit 2. patients with chronic stable angina who have severe coronary stenosis wich require pci. 3. patients who have at least one coronary plaque (≧ 500μm in thickness or % plaque of 20% or more) at the non-culprit vessels. 4. patients with hyperuricemia, who have a serum uric acid level \>7.0mg/dl within 2 months prior to enrollement. 5. patients who personally given written informed consent to participate in this study. exclusion criteria: 1. patients who had undergone previous pci for the lesion under investigation. 2. patients with gouty tophus, or patients with subjective symptoms of gouty arthritis within 1 year prior to enrollment. 3. patients with a previous history of hypersensitivity to febuxostat or allopurinol. 4. patients with serious kidney disease, acute kidney disease, nephrotic syndrome, dialysis patients, kidney transplant patients, egfr \< 30 ml/min/1.73m2, etc. 5. patients with aspartate aminotransferase (ast) or alanine aminotransferase (alt) 2 or more times the upper limit of normal. 6. patients on any of the following medications at enrollment mercaptopurine hydrate, azathioprine, vidarabine, or didanosine. 7. patients who receive any of the following medications for the treatment of hyperuricemia within 1 month prior to enrollment allopurinol, benzbromarone, probenecid, bucolome, topiroxostat, or febuxostat. 8. patients otherwise judged by the principal or sub-investigator to be unsuitable for the study.

Keywords: coronary artery disease hyperuricemia coronary plaque volume ivus
auditory rehabilitation and cognition in alzheimer patients

Conditions: Alzheimer's Disease; Hearing Loss

Summary: alzheimer disease is a neurodegenerative disease. recent studies suggest that subjects with hearing loss are more likely to develop alzheimer's disease. hearing loss can be consecutive to presbycusis and/or to central auditory dysfunction. standard audiometric measures with pure tone and speech intelligibility allow the diagnosis of presbycusis. however, to demonstrate central auditory dysfunction, specific audiometric tests as noisy and/or dichotic tests, are needed. actually, no consensus exists to investigate hearing loss in people with alzheimer's disease; therefore hearing loss may be an early manifestation of alzheimer's disease. until now, investigations and clinical procedure related to the diagnosis of alzheimer's disease ignored the hearing ability of the patient. however, the major part of care management and investigations implies the patient's communication ability with caregivers. hearing loss may be one of the most unrecognized deficit in subjects with alzheimer's disease. auditory rehabilitation with hearing aids could benefit to the patient to decrease cognitive decline but this management must be investigate during longitudinal studies in order to demonstrate their efficiency and need to be compared with a placebo.


Eligibility criteria:
inclusion criteria: * alzheimer patient * mini mental state examination= 15-25 or mild cognitive impairment * over 65 yo * sensorineural hearing loss with pure tone average over 30 db * language: french * able to sign the consent * affiliated to the french social security exclusion criteria: * conductive hearing loss * retrocochlear hearing loss * history of neurological disorders with consequences in hearing loss (vascular accident; brain surgery, cerebral tumors, head trauma with loss consciousness) * patient included in another study * french no spoken * chronic used of drugs or alcohol

Keywords: alzheimer hearing loss cognition quality of life hearing aids
study protocol for rosiglitazone versus gliclazide in diabetics with angina

Conditions: Angina Pectoris; Diabetes Mellitus, Type 2

Summary: the principle objective of the trial is to compare rosiglitazone to gliclazide in patients with type 2 diabetes mellitus and chronic stable angina to see how the subjects' angina status changes. angina status will be measured via exercise tolerance testing, 24-hour ecg testing and angina quality of life questionnaire.

ischaemic heart disease is one of the main complications of type 2 diabetes mellitus, both in terms of morbidity and mortality. reducing plasma glucose with hypoglycaemic agents has not been shown to improve cardiovascular mortality or morbidity. chronic stable angina is a common problem in patients with type 2 diabetes mellitus. we postulate that in subjects with uncontrolled type 2 diabetes mellitus (hba1c \>7.5%), on metformin therapy, and chronic stable angina that the addition of the insulin sensitiser, rosiglitazone to control their diabetes will improve their angina when compared to the addition of the hypoglycaemic agent gliclazide. this hypothesis is based on the fact that insulin resistance is an upstream mechanism common to both conditions. we will randomise such patients to 3 months therapy of rosiglitazone or gliclazide for 3 months, comparing angina status before and after by way of full bruce protocol exercise testing, 24 hour st segment analysis and angina questionnaire.

Eligibility criteria:
inclusion criteria: * chronic stable angina with ongoing symptoms. (the treatment goal being an improvement in symptoms) * participants will have uncontrolled diabetes (hba1c\>7.5) on metformin monotherapy (so the diabetes is not over treated) * participants will be diabetic for less than 8 years. exclusion criteria: * renal impairment (creatinine \>130mmol/l) * hepatic impairment (alt\>70u/l, ast\>80u/l) * any clinical signs of heart failure * physical disability precluding treadmill exercise tolerance testing * abnormal resting ecg (left or right bundle-branch block, left or right ventricular hypertrophy, ventricular preexcitation, q-wave myocardial infarction, digitalis therapy) * women of childbearing potential * women who are breastfeeding

Keywords: angina ischaemic heart disease diabetes
effect of anti tnf alpha therapy and their adverse effects in ankylosing spondylitis in a north indian population

Conditions: Ankylosing Spondylitis

Summary: ankylosing spondylitis (as) is a chronic painful progressive inflammatory arthritis of unknown etiology primarily affecting the spine and sacroiliac joints. in addition to formation of new bone leading to syndesmophytes and ankylosis; osteoporosis is also a prominent feature in as-thus showing the paradox of new bone formation at abnormal sites coexisting with reduced bone mass \& increased fracture risk. osteoporosis is a common complication of as, with an incidence between 18.7% and 62%. tnf alpha has a central role in disturbing this balance in bone metabolism--resulting in accelerated alveolar bone loss and decreased strength- i.e. osteoporosis. the investigators hypothesis that anti tnf therapy is effective in active as resistant to conventional therapy and helps in improving the bone density and over all bone health.

ankylosing spondylitis not responding to conventional therapy has been effectively treated with anti tnf therapy. in addition studies have shown that tnf has a role in osteoporosis of inflammatory diseases. the hypothesis that anti tnf therapy may decrease osteoporosis and tilt bone metabolism to the osteoblastic side has been tested in few studies. these have not been studied in an indian population. another great issue in the usage of anti tnf therapy in indian population is the high incidence of developing infective complications; especially tuberculosis. the investigators are thus studying these in a north indian population at a tertiary centre. the results would come to important conclusions regarding treatment and in the important issue of tuberculosis screening and prevention.

Eligibility criteria:
inclusion criteria: * patients who are fulfilling the modified new york criteria(1984) for the diagnosis of ankylosing spondylitis * age ≥ 18 years * patients who have been planned to be started on anti tnf alpha agents. * patients who have given consent for the study. exclusion criteria: * patients with other coexistent rheumatologic diseases. * patients who have previously received anti tnf alpha agents in the past 1 year. * patients who are receiving other medications that may significantly alter the bone metabolism (like steroids, bisphosphonates, estrogen replacement therapy etc) * patients with any contraindications against the usage of anti tnf alpha agents (active/ chronic infections, liver dysfunction, demyelinating diseases, pregnancy etc) * patients with other definite risk factors for osteoporosis like chronic alcoholism, smoking, endocrine disorders etc

Keywords: tnf bmd ankylosing spondylitis bone health anti tnf therapy disease activity
cognition and emotion in the sii and ibd

Conditions: Irritable Bowel Syndrome; Inflammatory Bowel Disease (IBD); Crohn's Disease(CD); Ulcerative Colitis

Summary: the study aims at showing that the susceptibility in the stress is more raised at the person affected digestive pathologies (sii or ibd) in forgiveness than healthy subjects.

the objective of the study which we wish to lead consists in looking for, at the patients sii and ibd in forgiveness, the existence of a correlation between the rate of cortisol(hormone of the stress) and the level of hrv (heart rate variability) to estimate the inhibitive fronto-amygdalien tonus. so we make the hypothesis that the persons affected by digestive pathologies of type sii or ibd would present an emotional and physiological vulnerability more important than unhurt subjects of pathologies.

Eligibility criteria:
inclusion criteria: * patients with sii :membership to the social security,sii defined according to the criteria rome iii. * patients with ibd :membership to the social security,patients with a ulcerative colitis(uc) or a crohn's disease (cd)ileal and/or colic. exclusion criteria: * existence of a severe affectation on the general plan (cardiac,respiratory,hematological,renal,hepatic,cancerous), * subject diabetic, * pregnant or breast-feeding woman, * subject included in another clinical and\\or therapeutic trial or having been included in a clinical and\\or therapeutic trial for less than a month, * subject presenting a psychiatric pathology evident, * person under guardianship.

Keywords: hrv emotion cognition stress cortisol autonomic nervous system
indocyanine angiographic changes of choroidal neovascularization by ranibizumab

Conditions: Exudative Age-related Macular Degeneration

Summary: exudative age-related macular degeneration (armd) is complicated by choroidal neovascularization (cnv). although anti-vascular endothelial growth factor treatment is the gold standard treatment, recurrence is the main limitation of the treatment. the changes of the cnv vascular structure is expected to provide information regarding recurrence. in the eyes that the vascular structure is clearly seen in indocyanine green angiography (icga), the vascular changes after ranibizumab injections will be investigated prospectively.

for patients having exudative armd with cnv, whose vascular structures are clearly demonstrated in icga , ranibizumab is injected monthly three times, then pro re nata to 6 months. vascular structures of cnv is investigated at baseline, 3 and 6 months using icga. expected number of patients are 48 eyes from 4 centers, competitively.

Eligibility criteria:
inclusion criteria: 1. age \>= 50 2. visual acuity of the study eye is between 20/400 and 20/40, and the other eye is 20/400 or better 3. area of choroidal new vessel (cnv) clearly visible in indocyanine green angiography (icga) is more then 1/2 disc area. 4. area of cnv clearly visible in icga is more than half of the total cnv area. exclusion criteria: 1. cnv caused by other than age-related macular degeneration. (polypoidal choroidal vascularization, retinal angiomatous proliferation, degenerative myopia etc) 2. blocked fluorescence in icga is more than half of the total cnv area. 3. disciform scar 4. previous anti-vascular endothelial growth factor (vegf) treatment within 3 months 5. previous any treatment of photodynamic therapy or photocoagulation 6. previous intraocular or periocular injection of steroid within 3 months 7. previous intraocular surgery except cataract surgery 8. vitreo-retinal interface disease on the macula 9. presence of other diseases may affect visual acuity (uveitis, glaucoma, diabetic retinopathy, etc.) 10. uncontrolled periocular or intraocular infection 11. history of hypersensitivity to ranibizumab treatment 12. uncontrolled systemic diseases (hypertension, diabetes mellitus, etc.)

Keywords: age-related macular degeneration choroidal neovascularization ranibizumab indocyanine angiography